Duns Number:080326793
Device Description: A package of 10 x UroShield disposable Actuators The UroShield is a single catheter use ac A package of 10 x UroShield disposable Actuators The UroShield is a single catheter use accessory that is clipped on the catheter's external part.After connection to the reusable Driver and activation, Actuator creates surface acoustic waves that cause small acoustic vibrations on the catheter surface to prevent bacteria adhesion to the catheter surface.
Catalog Number
10-200-0002
Brand Name
UroShield Actuaor 10 pack
Version/Model Number
3.0 Actuator
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
QMK
Product Code Name
Extracorporeal Acoustic Wave Generating Accessory To Urological Indwelling Catheter For Use During The Covid-19 Pandemic
Public Device Record Key
24d75dab-ab88-424e-b373-fafc180429be
Public Version Date
May 12, 2021
Public Version Number
1
DI Record Publish Date
May 04, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |